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临床试验/NCT06709573
NCT06709573招募中4 期

Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
300
试验地点
1
主要终点
Norepinephrine-equivalent dose

研究概览

简要总结

The goal of the CASPER-Pilot study is to develop clinical decision support (CDS) technology within Epic to randomize patients with septic shock to early versus standard of care vasopressin initiation. The primary aim of this study will be to test the hypothesis that CDS technology can be utilized to create two distinct cohorts of patients reflecting different times of vasopressin initiation based on norepinephrine dose requirements. Secondarily, this study will evaluate the proportion of patients whose norepinephrine dose at the time of vasopressin initiation is within the specified range for the intervention arm they were randomized to. Other outcomes of evaluation will include adherence to the developed CDS technology and comparison of clinical outcomes between the two treatment arms.

详细描述

Sepsis is a highly prevalent and morbid disease estimated to account for up to 20% of annual deaths globally. If not rapidly identified and intervened upon, patients with sepsis may progress to septic shock, which is associated with mortality rates up to 50%. Patients with septic shock have persistent hypotension requiring vasoactive agents to augment blood pressure despite fluid resuscitation. Norepinephrine is recommended first-line by the Surviving Sepsis Campaign (SSC) guidelines for patients with septic shock. If mean arterial pressure (MAP) remains inadequate on norepinephrine, vasopressin is suggested as the second-line adjunctive agent. Over 30% of patients with septic shock in the United States (US) receive adjunctive vasopressin, with use rising over time. Despite increased use over time, ideal patient selection and initiation timing for adjunctive vasopressin in the course of a patient's shock are not well elucidated. The 2021 iteration of the SSC guidelines note that initiating vasopressin when the patient requires between 0.25 and 0.5 mcg/kg/min of norepinephrine "seems sensible". Yet, many questions remain regarding the timing of vasopressin initiation. The goal of this proposal is to evaluate the timing of vasopressin initiation in patients with septic shock based on the norepinephrine requirements at the time of vasopressin initiation. This pilot study will attempt to develop CDS technology in which to answer this clinical question.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 Years
  • Diagnosis of Septic Shock
  • Admitted to Cleveland Clinic Main Campus Medical ICU
  • Receiving continuous infusion of norepinephrine at a dose > 5 mcg/min at time of enrollment

排除标准

  • Administration of any other vasoactive agent other than norepinephrine at time of enrollment
  • Initiation of vasopressin by provider outside of the context of study when NE < 10 mcg/min (before BPA firing)

研究组 & 干预措施

Standard of Care Vasopressin Initiation

Active Comparator

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min

干预措施: vasopressin - standard initiation (Drug)

Early Vasopressin Initiation

Experimental

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min

干预措施: vasopressin - early initiation (Drug)

结局指标

主要结局

Norepinephrine-equivalent dose

时间窗: Outcome evaluated on day of vasopressin initiation

The primary outcome is the norepinephrine-equivalent dose (in mcg/min) at the time of vasopressin initiation between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation

次要结局

  • Proportion of patients within goal norepinephrine-equivalent dose range(Outcome evaluated on day of vasopressin initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gretchen Sacha

Principal Investigator

The Cleveland Clinic

研究点 (1)

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